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FDA’s Accelerated Pathways Are the New Normal
The FDA’s Accelerated Approval, Breakthrough Therapy Designation, Fast Track, Orphan Drug status, and Qualified Infectious Disease Product pathways facilitate faster development and approval of NDAs addressing unmet needs. According to the FDA’s annual report, two-thirds of novel drugs approved in 2015 used at least one accelerated pathway, while a third used two or more. PAREXEL and the nonprofit Network for Excellence in Healthcare Innovation share results of a survey of twenty national, regional, public, and private payers, which explain how they view these pathways and products.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
